Label: RANITIDINE- ranitidine hydrochloride tablet, film coated 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

                                     

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  • Purpose

    Acid reducer

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  • Use(s)

    • Relieves heartburn associated with acid indigestion and sour stomach
    • Prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

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  • Warnings

    Allergy alert: Do not use if you are allergic to ranitidine or any other acid reducers.

    Do not use

    • with other acid reducers
    • if you have kidney disease, except under the advice and supervision of a doctor
    • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor

    Ask a doctor before use if you have

    • nausea or vomiting
    • stomach pain
    • unexplained weight loss
    • frequent chest pain
    • frequent wheezing, particularly with heartburn
    • had heartburn over 3 months. This may be a sign of a more serious condition.
    • heartburn with lightheadedness, sweating or dizziness
    • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

    Stop use and ask a doctor if

    • your heartburn continues or worsens
    • you need to take this product for more than 14 days

    Pregnancy/Breastfeeding

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Adults and Children 12 years and over:

    • to relieve symptoms, swallow 1 tablet with a glass of water
    • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
    • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
    • do not chew tablet
    • children under 12 years: ask a doctor

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  • Other Information

    • do not use if bottle seal is open or torn
    • store at 20° to 25°C (68° to 77°F)
    • protect from light
    • this product is sodium and sugar free
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  • Inactive Ingredients

    carnauba wax, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, vanillin, red and yellow ferric oxide.

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  • Questions or Comments?

    Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) 

    Consumer Information

    What you should know about

    MAXIMUM STRENGTH 

    Ranitidine Tablets USP, 150 mg / Acid Reducer 

    (Please read all this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference)

    What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

    MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride, 168 mg), a medicine that doctors have prescribed more than 200 million times  worldwide.

    What symptoms do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg treat and prevent?

    MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieves and prevents heartburn associated with acid indigestion and sour stomach. 

    Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion and sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.

    ran-150mg-otc-esophagus 

    Excellent Safety Record

    • The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications.
    • MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg are sodium and sugar free.

    How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

    • To relieve symptoms, swallow 1 tablet with a glass of water.
    • To prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn.

    This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours). 

    MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg should not be given to children under 12 years old unless directed by a doctor.

    How do MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work?

    MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduces the production of stomach acid. This is what makes MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.

    Tips for managing heartburn

    • Do not lie flat or bend over soon after eating
    • Do not eat late at night, or just before bedtime
    • Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
    • Eat slowly and do not eat big meals
    • If you are overweight, lose weight
    • If you smoke, quit smoking
    • Raise the head of your bed
    • Wear loose fitting clothing around your stomach
    • Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

    When should I see a doctor?

    • Do not use  
      • with other acid reducers
      • if you have kidney disease, except under the advice and supervision of a doctor 
      • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. 
    • Ask a doctor before use if you have
      • nausea or vomiting
      • stomach pain
      • unexplained weight loss
      • frequent chest pain
      • frequent wheezing, particularly with heartburn
      • had heartburn over 3 months. This may be a sign of a more serious condition
      • heartburn with lightheadedness, sweating or dizziness
      • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
    • Stop use and ask a doctor if
      • your heartburn continues or worsens
      • you need to take this product for more than 14 days

    • If pregnant or breast feeding, ask a health professional before use.
    • Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center right away.

    Questions or Comments?

    Call 1-800-706-5575 (Monday to Friday, 8:30 am – 5:00 pm Eastern Standard Time) 

    Manufactured by:                   Manufactured for:

    Apotex Inc.                           Apotex Corp.

    Toronto, Ontario                    Weston, FL

    Canada M9L 1T9                   33326

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  • Principal Display Panel

    OTC Medicine

    Maximum Strength

    Rantidine Tablets USP, 150 mg

    ran-150mg-otc-label

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  • INGREDIENTS AND APPEARANCE
    RANITIDINE 
    ranitidine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:60505-2880
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ranitidine hydrochloride (ranitidine) ranitidine 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    carnauba wax  
    silicon dioxide  
    hypromelloses  
    magnesium stearate  
    cellulose, microcrystalline  
    polydextrose  
    titanium dioxide  
    vanillin  
    ferric oxide red  
    ferric oxide yellow  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60505-2880-7 10000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA200172 07/15/2013
    Labeler - Apotex Corp. (845263701)
    Registrant - Apotex Inc. (209429182)
    Establishment
    Name Address ID/FEI Business Operations
    Apotex Inc 209429182 manufacture(60505-2880)
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